Conducting clinical trials in five Eastern European countries (EU-EECs) with a focus on Bulgaria

Abstract

Data for ongoing and completed clinical trials (Phases I-III) were extracted from the European Union Clinical Trials Register for five EU-EECs (Bulgaria, Hungary, Poland, Romania and Slovakia) (from January 1, 2012 to September 30, 2022). Based on the almost 11-year period Poland (n = 4134) and Hungary (n = 3845) represent the largest share of trials, with over 250–300 ongoing and completed clinical trials a year. Bulgaria (with a population of 7 mill. inhabitants) has a lower number of completed and ongoing trials (n = 2049) versus Poland and Hungary, which, however, have much larger populations (Poland − 38 mill., Hungary − 9.8 mill.). Slovakia (5.5 mill. inhabitants), has 67% fewer ongoing and completed clinical trials (n = 1374) than Poland, while Hungary and Bulgaria also have more trials than Slovakia (64% and 33% respectively). The prevalence of trials in all EEC countries was calculated per 100,000 inhabitants, where Hungary (n = 39) ranks first, while Bulgaria (n = 29) is ahead of Slovakia (n = 25), Poland (n = 11) and Romania (n = 5). The ongoing and completed clinical trials conducted in the ten EU-EECs (n = 19030) have shown remarkable expansion over the past decade, accounting for a large share (26.3%) of all EU-wide trials (n = 72215) for the referenced period. The leader of the western EU countries, in terms of trials per 100,000 inhabitants is Denmark (n = 56) followed by Belgium (n = 44), Austria (n = 33), Finland (n = 30) and the Netherlands (n = 30). These results demonstrate that the number of completed and ongoing trials does not correspond to the size of a country’s population.

Keywords:

• Clinical trials register
• completed and ongoing clinical trials
• regulatory requirements
• rare disease indication
• distribution by clinical trial phase

Data availability statement

Data are based on the EU Clinical Trials Register, which is open and data extraction is given under every figure and is under Reference [4] EU Clinical Trials Register, https://www.clinicaltrialsregister.eu

EUROSTAT. GDP per capita in PPS, https://ec.europa.eu/eurostat/databrowser/view/tec00114/default/table?lang=en

EUROSTAT. Total population of the European Union, https://ec.europa.eu/eurostat/cache/digpub/demography/vis/00_00_00/index.html?lang=en

Disclaimer

The views and opinions expressed in the article are those of the individual authors, they are not attributable to their employers and do not present any official view of any company or any department thereof.

Author contributions

T.B. study design and first draft of the manuscript; different parts of the analysis, literature searches and text order, final version of the analysis, linguistic check and journal requirements; D.M. data extraction from different clinical databases, figures, different parts of the analysis, literature searches and text order; V.K. different parts of the study analysis, linguistic check and journal requirements; I.I. and D.D. the data extraction from different clinical databases, figures, linguistic check and journal requirements; V.T., literature searches and text order; N.D. and I.C., different parts of analysis; L.T. different parts of analysis, final version of the analysis and the journal requirements; L.G. different parts of analysis and final version of the analysis. All authors have read and approved the final manuscript.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.